IP Library Granted Patent US 11,040,056
Granted Patent B2
US 11,040,056 · App. 16/409,173 · Granted Jun 22, 2021

Benzimidazoles that enhance the activity of oligonucleotides

Inventors: Rudolph L. Juliano (Chapel Hill, NC); Silvia M. Kreda (Mebane, NC); Ling Wang (Chapel Hill, NC); Xin Ming (Chapel Hill, NC); Lindsey Ingerman James (Chapel Hill, NC); Ranathunga Arachchillage Yamuna Kumari Ariyarathna (Carrboro, NC)
Assignee: THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
A61K31/7125A61K31/4184A61K31/4985A61P11/00C07D235/30C12N15/113C12N2310/314C12N2310/3233C12N2320/31C12N2320/33
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Quick Facts
Patent No.
US 11,040,056
App. No.
16/409,173
Granted
Jun 22, 2021
Kind
B2
Abstract

This disclosure is directed to methods, compounds and compositions for delivering nucleic acids to a cell of interest. In particular, it provides salts that are particularly effective in delivering nucleic acids to cells in the lung for disorders such as cystic fibrosis (CF).

Claims (58)

1. A compound having the Formula I:

wherein:

R 1 is a pyrrolidine group;

R 2 -R 5 are each independently C 1-8 alkyl, C 1-8 alkoxy, C 2-8 alkenyl, C 3-8 alkynyl, C 3-8 cycloalkyl, H or halogen;

n is an integer between 1 and 8;

or a pharmaceutically acceptable salt thereof.

2. The compound of claim 1 , wherein n is 2-4 and R 1 is a pyrrolidine group.

3. The compound of claim 1 , wherein n is 2-4 and R 2 -R 5 are each independently C 1-4 alkyl, C 1-4 alkoxy, H or halogen.

4. The compound of claim 3 , wherein the halogen is bromine or chorine.

5. A composition comprising the compound of claim 1 , wherein the composition further comprises a compound having the Formula II:

wherein:

R 8 is C 1-8 alkyl or a linking group;

R 9 is C 1-8 alkyl or a linking group;

R 10 is C 1-8 alkyl;

R 11 and R 12 are each independently aryl, C 1-8 alkyl, C 1-8 alkoxy, amino, H, halogen, or heteroaryl;

or a pharmaceutically acceptable salt thereof.

6. The composition of claim 5 , wherein the compound of Formula II has the structure:

or a pharmaceutically acceptable salt thereof.

7. A composition comprising an oligonucleotide and a compound having the Formula I:

wherein:

R 1 is a pyrrolidine group;

R 2 -R 5 are each independently C 1-8 alkyl, C 1-8 alkoxy, C 2-8 alkenyl, C 3-8 alkynyl, C 3-8 cycloalkyl, H or halogen;

n is an integer between 1 and 8; and

a pharmaceutically acceptable carrier.

8. The composition of claim 7 , wherein the composition further comprises a compound having the Formula II:

wherein:

R 8 is C 1-8 alkyl or a linking group;

R 9 is C 1-8 alkyl or a linking group;

R 10 is C 1-8 alkyl;

R 11 and R 12 are each independently aryl, C 1-8 alkyl, C 1-8 alkoxy, amino, H, halogen, or heteroaryl;

or a pharmaceutically acceptable salt thereof.

9. The composition of claim 8 , wherein the compound of Formula II has the structure:

or a pharmaceutically acceptable salt thereof.

10. The composition of claim 1 , wherein the oligonucleotide is a phosphorodiamidate morpholino oligomer (PMO).

11. A method of administering an oligonucleotide of interest to a cell which comprises administering to the cell the oligonucleotide and a compound of Formula I:

wherein:

R 1 is a pyrrolidine group;

R 2 -R 5 are each independently C 1-8 alkyl, C 1-8 alkoxy, C 2-8 alkenyl, C 3-8 alkynyl, C 3-8 cycloalkyl, H or halogen;

n is an integer between 1 and 8;

or a pharmaceutically acceptable salt thereof.

12. The method of claim 11 , further comprising administering to the cell a compound having the Formula II:

wherein:

R 8 is C 1-8 alkyl or a linking group;

R 9 is C 1-8 alkyl or a linking group;

R 10 is C 1-8 alkyl;

R 11 and Ria are each independently aryl, C 1-8 alkyl, C 1-8 alkoxy, amino, H, halogen, or heteroaryl;

or a pharmaceutically acceptable salt thereof.

13. The method of claim 11 , wherein the oligonucleotide is a phosphorodiamidate morpholino oligomer (PMO).

14. The method of claim 11 , wherein the method is carried out by administering the oligonucleotide to the cell, and concurrently administering the compound having formula I to the cell.

15. The method of claim 11 , wherein the compound having formula I is administered after the oligonucleotide is administered to the cell.

16. The method of claim 11 , wherein the oligonucleotide is an antisense oligonucleotide.

17. The method of claim 11 , wherein the oligonucleotide is a splice switching oligonucleotide.

18. The method of claim 11 , wherein the oligonucleotide is an siRNA.

19. The method of claim 11 , wherein the cell is a lung cell or an airway cell.

20. The method of claim 19 , wherein the lung cell is a human bronchial epithelial cell (HBEC), a human nasal epithelial cell (HNEC), a mouse tracheal epithelial cell (MTEC), a human alveolar type I or type II cell, a human lung submucosal gland cell, a human lung leucocyte, or a human lung inflammatory cell.

21. The compound of claim 1 , wherein the compound of Formula I has the structure:

22. The composition of claim 7 , wherein the compound of Formula I has the structure:

23. The method of claim 11 , wherein the compound of Formula I has the structure:

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 12, 2019
From: JULIANO, RUDOLPH L.; KREDA, SILVIA M.; WANG, LING; MING, XIN; JAMES, LINDSEY INGERMAN; ARIYARATHNA, RANATHUNGA ARACHCHILLAGE YAMUNA KUMARI
To: THE UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL
Reel/Frame 050359/0346 →
CONFIRMATORY LICENSE Recorded Jul 23, 2019
From: UNIV OF NORTH CAROLINA CHAPEL HILL
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 049831/0583 →
Continuity (2)
Provisional Application 62670431 · May 11, 2018
Related Publication 20190343868A1 · Nov 14, 2019